India’s pharmaceutical sector marked a significant milestone in 2023, securing the 11th position in global export value. Contributing 3% to the world’s total pharmaceutical exports, the industry continues to expand its footprint, reinforcing India’s status as a key player in global healthcare.
To maintain high standards of medicine quality, the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have intensified regulatory efforts. Since December 2022, risk-based inspections have been conducted across drug manufacturing and testing units. Out of 905 facilities inspected, 694 faced regulatory actions, including license suspensions and production halts, addressing concerns over non-compliance with safety and efficacy standards.
Stricter penalties have also been enforced under the Drugs and Cosmetics Act of 1940, which was amended in 2008 to impose severe consequences for the production of spurious or adulterated drugs. These measures aim to strengthen India’s pharmaceutical industry by ensuring that exported medicines meet global quality benchmarks.
With these regulatory enhancements, India is not only reinforcing its credibility in the global pharmaceutical market but also ensuring that its exports remain synonymous with safety and reliability.